CEFID-II (CEra Flow Improves DVT-II)

NCT05511064 | Completed

• 1 other identifier: CGM-21-031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

For Deep Vein Thrombosis (DVT) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name CGM MB-1701).

Conditions

Blood Circulation Disorder; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Peak Systolic Velocity (PSV) change

  Compare the PSV change in the right lower extremity femoral vein at 10 days (V4) after application of the test device compared to the baseline (V2).

  10 days from the baseline

Secondary Outcomes (4)

• Peak Systolic Velocity (PSV) change

  5 days from the baseline

• Anteroposterior (AP) diameter

  5 days (V3) and 10 days (V4) from the baseline

• Cross Sectional Area (CSA)

  5 days (V3) and 10 days (V4) from the baseline

• Leg volume (3D scanner)

  5 days (V3) and 10 days (V4) from the baseline

Study Arms (1)

blood circulation treatment

EXPERIMENTAL

Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)

Device: Blood circulation device

Interventions

Blood circulation device DEVICE

Blood circulation device of CGM MB-1701

blood circulation treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women over 19 years of age
• Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices.
• (1) Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea (2) D-dimer negative test result (Even if D-dimer is tested positive, it can be selected through additional tests at the discretion of investigator.)
• \. Subjects have 2 or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells score) at the time of screening.
• \. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent

You may not qualify if:

• Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain
• Subjects have inflammation or trauma on the skin that directly touches the device

Sponsors & Collaborators

• Ceragem Clinical Inc.: lead

Study Sites (3)

Presbyterian Medical Center

Jeonju, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joon-shik Yoon, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: December 22, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)